BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY IOL WITH TECNIS SIMPLICITY DELIVERY SYSTEM

    MDR report key: 20340490 · Received September 30, 2024

    Report

    Report Number
    3012236936-2024-000253
    Event Type
    Injury
    Date Received
    September 30, 2024
    Report Date
    March 27, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: UPON FURTHER REVIEW OF THE EVENT, IT WAS DETERMINED THAT THE REPORTED INCIDENT DID NOT CONSTITUTE A SERIOUS INJURY THAT COULD CAUSE A DEBILITATING CONDITION AND NO MEDICAL OR SURGICAL INTERVENTION WERE PERFORMED. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER MFR REPORT NUMBER 3012236936-2024-0002536. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION E1 - TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED, AND THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED, AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF SYMPTOMS SIMILAR TO WAXY VISION AFTER INTRAOCULAR LENS (IOL) IMPLANTATION ALTHOUGH THE PATIENT HAD VISUAL ACUITY. NO PATIENT INJURY WAS REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40696 TECNIS SYNERGY IOL WITH TECNIS SIMPLICITY DELIVERY SYSTEM LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFR00V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other